BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 6868592 · Received September 15, 2017

    Report

    Report Number
    1226348-2017-00149
    Event Type
    Injury
    Date Received
    September 15, 2017
    Date of Event
    October 1, 2013
    Report Date
    August 23, 2017
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUBMISSION IS RELATED TO A LITERATURE ARTICLE DISCOVERED TO SUPPORT THE CER SUBMISSION PROCESS, AS SUCH, THE ASSOCIATED TIME FRAME OF EVENT DATES INCLUDES BUT IS NOT LIMITED TO 20 YEARS. THESE ARTICLES ARE BEING REVIEWED MONTHLY FOR SAFETY SIGNALS AND WILL BE FOLLOWED BY MONTHLY TRENDING ASSESSMENTS AS WELL AS PMS REVIEWS. ARTICLE ATTACHED TO THE MDR: RHO, M.H., PARK, H.J., CHUNG, E.C. ET AL. (2013). VARIOUS TECHNIQUES OF STENT-ASSISTED COIL EMBOLIZATION OF WIDE-NECKED OR FUSIFORM ARTHEROSCLEROTIC AND DISSECTING UNRUPTURED VERTEBROBASILAR ARTERY ANEURYSMS FOR REDUCING RECANALIZATION: MID-TERM RESULTS, ACTA NEUROCHIR (2013) 155:2009¿2017, DOI 10.1007/S00701-013-1866-Y. DATE OF EVENT, PRODUCT CODE, AND LOT NUMBER COULD NOT BE OBTAINED FROM THE AUTHOR. UDI: UNKNOWN PART NUMBER, ATTEMPTS TO OBTAIN PRODUCT PART NUMBER WERE UNSUCCESSFUL, UDI UNAVAILABLE. CONCLUSION: THE DEVICES WERE NOT AVAILABLE FOR ANALYSIS. IN ADDITION, NO LOT NUMBERS COULD BE OBTAINED; THEREFORE, A DHR COULD NOT BE PERFORMED FOR THE DEVICES. THROMBOEMBOLISM IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE ENTERPRISE DEVICE AND CEREBRAL STENTING PROCEDURES AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU). IT IS NOT POSSIBLE TO DETERMINE THE EXACT CAUSE OF THE EVENT; HOWEVER, PROCEDURAL AND PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. THE IFU STATES ¿THE PERFORMANCE AND SAFETY OF TWO OR MORE OVERLAPPING STENTS NOT BEEN ESTABLISHED. THERE IS NO CURRENT SAFETY SIGNAL IDENTIFIED RELATED TO THE REPORTED EVENT BASED ON REVIEW OF COMPLAINT HISTORY FOR THE DEVICE. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THERE IS NO NEW INFORMATION TO REPORT AT THIS TIME. THE REPORT IS BEING SUBMITTED TO CORRECT THE SEQUENTIAL NUMBERING OF THE FOLLOW-UP REPORTS PER FDA'S REQUEST. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER POSTAL CODE: (B)(6). THIS MDR INVOLVED 2 ENTERPRISE STENTS. NO DEVICE SPECIFIC INFORMATION COULD BE OBTAINED. AT THE TIME OF COMPLAINT ENTRY, NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE. THIS SUBMISSION IS RELATED TO A LITERATURE ARTICLE DISCOVERED TO SUPPORT THE CER SUBMISSION PROCESS, AS SUCH, THE ASSOCIATED TIME FRAME OF EVENT DATES INCLUDES BUT IS NOT LIMITED TO 20 YEARS. THESE ARTICLES ARE BEING REVIEWED MONTHLY FOR SAFETY SIGNALS AND WILL BE FOLLOWED BY MONTHLY TRENDING ASSESSMENTS AS WELL AS PMS REVIEWS. ARTICLE ATTACHED TO THE MDR: RHO, M.H., PARK, H.J., CHUNG, E.C. ET AL. (2013). VARIOUS TECHNIQUES OF STENT-ASSISTED COIL EMBOLIZATION OF WIDE-NECKED OR FUSIFORM ARTHEROSCLEROTIC AND DISSECTING UNRUPTURED VERTEBROBASILAR ARTERY ANEURYSMS FOR REDUCING RECANALIZATION: MID-TERM RESULTS. ACTA NEUROCHIR (2013) 155:2009¿2017, DOI 10.1007/S00701-013-1866-Y DATE OF EVENT, PRODUCT CODE, AND LOT NUMBER COULD NOT BE OBTAINED FROM THE AUTHOR. UDI: UNKNOWN PART NUMBER, ATTEMPTS TO OBTAIN PRODUCT PART NUMBER WERE UNSUCCESSFUL, UDI UNAVAILABLE. THERE WILL BE THREE MDRS SUBMITTED FOR THIS LITERATURE ARTICLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿VARIOUS TECHNIQUES OF STENT-ASSISTED COIL EMBOLIZATION OF WIDE-NECKED OR FUSIFORM ARTHEROSCLEROTIC AND DISSECTING UNRUPTURED VERTEBROBASILAR ARTERY ANEURYSMS FOR REDUCING RECANALIZATION: MID-TERM RESULTS¿ BY MYUNG HO RHO & HEE JIN PARK & EUN CHUL CHUNG & YOON JUNG CHOI & SO YEON LEE & YU SAM WON & BYUNG MOON KIM, PUBLISHED ACTA NEUROCHIR (2013) 155:2009¿2017, DOI 10.1007/S00701-013-1866-Y, IT WAS REPORTED THAT PATIENT # 19, A (B)(6) YEAR-OLD MALE WITH INCIDENTAL FINDING OF BASILAR TIP ANEURYSM, SIZE 10.7MM, HAD 2 UNKNOWN ENTERPRISE STENTS IMPLANTED IN IN A Y-FORMATION AND SUFFERED AN ASYMPTOMATIC THROMBOEMBOLISM. THE PATIENT WAS IN STABLE CONDITION AT THE 12-MONTH FOLLOW-UP. THE AIM OF THE RETROSPECTIVE STUDY DISCUSSED IN THE ARTICLE WAS TO EVALUATE COMPLICATIONS AND MID-TERM OUTCOMES OF COMPLEX VERTEBROBASILAR ARTERY ANEURYSMS AFTER STENT-ASSISTED COILING, INVOLVING 28 CASES OF UNRUPTURED ANEURYSMS. THE PATIENTS WERE TREATED BETWEEN APRIL 2006 AND SEPTEMBER 2012. THERE WERE 13 WOMEN AND 15 MEN, WITH THE MEAN AGE OF 56.4 YEARS. CLOPIDOGREL (75MG DAILY) AND ASPIRIN (100MG DAILY) WERE STARTED 5¿7 DAYS PRIOR TO THE PROCEDURE. ON THE DAY BEFORE TREATMENT, PATIENTS WERE GIVEN A LOADING DOSE OF CLOPIDOGREL (300 MG) AND ASPIRIN (100 MG) IF ANTIPLATELET THERAPY WAS NOT GIVEN. PATIENTS WERE THEN KEPT UNDER DUAL ANTIPLATELET THERAPY (CLOPIDOGREL, 75 MG, AND ASPIRIN, 100 MG) DAILY FOR 6 MONTHS FOLLOWED BY ASPIRIN ALONE DAILY FOR 12 MONTHS. ANTICOAGULATION WAS PROVIDED WITH AN INJECTION OF A 3000¿4000 IU BOLUS OF HEPARIN INTRAVENOUSLY AT THE BEGINNING OF THE PROCEDURE, FOLLOWED BY CONTINUOUS INFUSION OF HEPARIN AT 1000 IU/H. ACTIVATED COAGULATION TIME WAS MAINTAINED BETWEEN TWO AND THREE TIMES THE BASELINE VALUE DURING THE PROCEDURE AND FOR 24 TO 48 HOURS AFTER THE PROCEDURE. NON-CODMAN COILS WERE USED DURING THE PROCEDURE. THE ARTICLE CONCLUDED THAT COMPLEX VERTEBROBASILAR ANEURYSM EMBOLIZATION WITH STENT-ASSISTED TECHNIQUES WAS EFFECTIVE AND FEASIBLE AS A METHOD FOR REDUCING RECANALIZATION DURING MIDTERM ANGIOGRAPHIC FOLLOW-UP. THE LOT AND CATALOG NUMBERS OF THE ENTERPRISE STENTS WERE NOT PROVIDED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649292 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Life Threatening| R UNK.